EXtubation Related Complications - the EXTUBE Study (EXTUBE)
ConditionExtubation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
EXTUBE is an international, multicentre, prospective cohort study evaluating the incidence, risk factors, and outcomes of extubation-related complications and describing clinical practices related to extubation after general anesthesia or after critical illness in the operating room (OR), out of OR anesthesia location or intensive care unit (ICU).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years old)
Undergoing extubation of an endotracheal tube (including index extubation and re-extubations) after general anesthesia in the OR, out of OR anesthesia location or ICU
Undergoing extubation during the specified enrollment window
Disqualifiers
Patients will be excluded if the extubation is performed in the context of withdrawal of life support measures,
Patients will be excluded if the extubation is performed for tracheostomy decannulation
Trial population
All adult patients (≥18 years old) undergoing extubation of an endotracheal tube (including index extubation and re-extubations) after general anesthesia in the OR, out of OR anesthesia location or ICU during the specified enrollment window (up to 4 weeks).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
At least one of the following, occurring within 60minutes after extubation (composite outcome): i) Severe hypoxemia ii) Cardiac arrest iii) Need for airway management
The primary outcome will be the occurrence of at least one of the following (composite outcome) occurring within 60 minutes after the end of extubation: i) Severe hypoxemia (oxygen saturation as measured by pulse oximetry falls below SpO2 \< 80% for \> 5 minutes) ii) Cardiac arrest iii) Need for airway management (reintubation, insertion of a supraglottic airway, bag-mask ventilation).
Time frame
Within 60 minutes after the end of extubationSecondary outcomes
1
Difficult airway and complications related to airway management if reintubation is required
Difficult airway (i.e., experienced difficulty by an experienced airway manager with any or all of laryngoscopy or tracheal intubation, supraglottic airway use, face-mask ventilation, or front-of-neck airway) and complications related to airway management (e.g., esophageal intubation) if reintubation is required
Time frame
Within 60 minutes after the end of extubation2
Planned and unplanned non-invasive respiratory support
Planned and unplanned non-invasive respiratory support or high flow nasal cannula
Time frame
Within 60 minutes after the end of extubation3
Emergency front of neck airway
Emergency front of neck airway should airway management be required after extubation
Time frame
Within 60 minutes after the end of extubation4
Cardiac arrhythmia requiring chemical or electrical treatment
Cardiac arrhythmia requiring chemical or electrical treatment
Time frame
Within 60 minutes after the end of extubationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov